Low-Dose Tamoxifen Citrate in Reducing Breast Cancer Risk in Radiation-Induced Cancer Survivors
NCT01196936 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 84
Last updated 2026-01-05
Summary
Estrogen can cause the growth of breast cancer cells. Hormone therapy using tamoxifen citrate may fight breast cancer by blocking the use of estrogen by the tumor cells
This phase IIb trial studies how well low-dose tamoxifen citrate works in reducing breast cancer risk in radiation-induced cancer survivors.
Conditions
Interventions
- DRUG
-
Tamoxifen Citrate
5 mg PO Daily
- DRUG
-
1 tablet daily
- PROCEDURE
-
Digital mammography
Correlative studies
- OTHER
-
immunohistochemistry staining method
Correlative Studies
- OTHER
-
pharmacological study
Correlative Studies
- OTHER
-
laboratory biomarker analysis
Correlative Studies
- GENETIC
-
protein expression analysis
correlative studies
- OTHER
-
pharmacogenomic studies
correlative studies
- OTHER
-
questionnaire administration
Ancillary studies
- PROCEDURE
-
Fine needle aspiration
- OTHER
-
Quality of Life Assessment
Ancillary Studies
Sponsors & Collaborators
-
National Cancer Institute (NCI)
collaborator NIH -
St. Jude Children's Research Hospital
collaborator OTHER -
University Health Network, Toronto
collaborator OTHER - collaborator OTHER
- collaborator OTHER
- collaborator OTHER
- collaborator OTHER
-
City of Hope National Medical Center
collaborator OTHER -
M.D. Anderson Cancer Center
collaborator OTHER -
University of Chicago
collaborator OTHER - collaborator OTHER
-
University of Colorado, Denver
collaborator OTHER -
Wake Forest University
collaborator OTHER -
University of Alabama at Birmingham
lead OTHER
Principal Investigators
-
Smita Bhatia, MD · University of Alabama at Birmingham
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 25 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2010-09-30
- Primary Completion
- 2018-12-11
- Completion
- 2028-12-11
Countries
- United States
- Canada
Study Locations
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